Senologie - Zeitschrift für Mammadiagnostik und -therapie 2021; 18(02): e11-e12
DOI: 10.1055/s-0041-1730162
Abstracts
Senologie

MONARCH 2: subgroup analysis of patients receiving abemaciclib+fulvestrant as first- and second-line therapy for HR+, HER2- advanced breast cancer (ABC)

EM Grischke
1   Universitätsklinikum Tübingen Frauenklinik, Tübingen, Deutschland
,
P Neven
2   Universitaire Ziekenhuizen Leuven, Leuven, Belgien
,
S Johnston
3   The Royal Marsden NHS Foundation Trust, London, Vereinigtes Königreich
,
M Toi
4   Graduate School of Medicine, Kyoto University, Kyoto, Japan
,
J Sohn
5   Yonsei Cancer Center, Yonsei University College of Medicine, Seoul, Korea, Republik
,
K Inoue
6   Saitama Cancer Center, Saitama, Japan
,
X Pivot
7   Centre Paul Strauss, Strasbourg, Frankreich
,
O Burdaeva
8   Arkhangelsk Regional Clinical Oncology Dispensary, Arkhangelsk, Russische Föderation
,
M Okera
9   Adelaide Cancer Centre, Adelaide, Australien
,
N Masuda
10   National Hospital Organization, Osaka National Hospital, Osaka, Japan
,
H Koh
11   Kaiser Permanente, Bellflower, Vereinigte Staaten von Amerika
,
P Conte
12   DiSCOG University of Padova and Medical Oncology, Istituto Oncologico Veneto, I.R.C.C.S., Padova, Italien
,
Y Lu
13   Eli Lilly and Company, Indianapolis, Vereinigte Staaten von Amerika
,
N Haddad
13   Eli Lilly and Company, Indianapolis, Vereinigte Staaten von Amerika
,
K Hurt
13   Eli Lilly and Company, Indianapolis, Vereinigte Staaten von Amerika
,
P Kaufman
14   University of Vermont Cancer Center, Burlington, VT, Vereinigte Staaten von Amerika
,
A Llombart-Cussac
15   Hospital Arnau de Vilanova, Valencia, Spanien
,
G Sledge
16   Stanford University School of Medicine, Stanford, Vereinigte Staaten von Amerika
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Goal In MONARCH 2 (M2), abemaciclib+fulvestrant demonstrated statistically significant improvements in PFS and OS versus placebo+fulvestrant in hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) ABC. Numerically more pronounced PFS and OS improvement was noted in subgroups with visceral disease and primary endocrine resistance. We report efficacy data for M2 with respect to 1L and 2L subgroups (last line of endocrine therapy [ET] in (neo)adjuvant and metastatic setting, respectively).

Material/method In M2 (global, randomised, double-blind Phase3 trial of abemaciclib+fulvestrant [n = 446]/placebo+fulvestrant [n = 223]), women with ET-resistant (ETR), HR+, HER2- ABC regardless of menopausal status were stratified by site of metastasis (visceral, bone-only, other) and resistance to prior ET (primary versus secondary). Exploratory subgroup analyses of PFS and OS were conducted in ITT patients with 1L versus 2L. Hazard ratios (HR) were estimated using Cox models.

Results At data cut-off (June-20-2019), effect of abemaciclib+fulvestrant versus placebo+fulvestrant was consistent across 1L (n = 265/133) and 2L (n = 170/86) subgroups (no statistically significant interaction for PFS[p=0.341] or OS[p=0.265]). For 1L patients, PFS(HR=0.57; 95 %CI=0.45,0.73) and OS(HR=0.85; 95 %CI=0.64, 1.14) improved. Similar efficacy results were observed for 2L patients (PFS: HR=0.48[95 %CI=0.36,0.64]; OS: HR=0.66[95 %CI=0.46,0.94]). Numerically largest effects in 1L population were noted in patients with less favourable prognostic factors like primary ETR (PFS: HR=0.40[95 %CI=0.26,0.63]; OS: HR=0.58[95 %CI=0.35, 0.97]) and visceral disease (PFS: HR=0.54[95 % CI=0.39,0.73]; OS: HR=0.82[95 %CI=0.57, 1.17]).

Summary Statistically significant benefit observed in M2 was consistent across 1L and 2L patients. In 1L patients (abemaciclib+fulvestrant), PFS and OS improved (most pronounced effects noted in patients with less favourable prognostic factors).



Publication History

Article published online:
01 June 2021

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